Impureza de Abacavir-1-O-pyrimidine Derivative apresenta perfil crítico para controle analítico e regulatório. Caracteriza-se por massa molecular próxima ao princípio ativo | retenção tardia em HPLC e sinais específicos em LC-MS e espectroscopia de RMN que permitem identificação estrutural. Pode originar-se por reações secundárias durante síntese ou por degradação térmica e oxidativa em condições de stress. A quantificação precisa exige métodos validados com limites de detecção e quantificação estabelecidos | critérios de aceitabilidade e amostragem representativa. Estratégias de controle incluem otimização do processo | purificação cromatográfica e monitoramento de estabilidade para garantir conformidade com especificações de qualidade.
Referências
“Abacavir: MedlinePlus Drug Information.â€Â Medlineplus.gov, Jan. 2022, medlineplus.gov/druginfo/meds/a699012.html.
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